S/T Patient Guide
1004221 JR 3/15/01
Contents 1 Warnings, Cautions, and Notes... 3 Warnings... 3 Cautions... 4 Temperatures... 4 Intended Use/Indications for Use... 5 Contraindications... 5 1 Contents of the Package... 6 2 Introduction to the Harmony S/T... 7 What is Bi-Level Ventilation?... 7 What is the Harmony S/T?... 8 Symbols... 9 How to Contact Respironics... 9 3 A Tour of the Harmony S/T... 10 Overview... 10 Top Panel... 11 Connecting the Breathing Circuit... 12 Rear Panel... 12
2 4 Using the Harmony S/T... 13 Installing the Inlet Filters... 13 Where to Place the Harmony S/T Unit... 14 Connecting the Breathing Circuit... 14 Complete Harmony S/T Setup... 16 Plugging the Unit In (Using AC Power)... 17 Using DC Power... 17 Starting the Harmony S/T Unit... 18 Adjusting the Rise Time... 18 5 Alarms and What to Do... 19 6 Troubleshooting... 23 Mask Discomfort and Corrective Actions... 24 7 Cleaning the Unit and Filters... 27 Cleaning Your Harmony Unit... 27 Cleaning/Replacing the Inlet Filters... 28 8 Using Oxygen with your Harmony Ventilator... 30 Limited Warranty... 35
Warnings, Cautions, and Notes Warnings A Warning indicates the possibility of injury to you or the operator of the device. This manual serves as a reference. The instructions in this manual are not intended to supersede the instructions of your care giver. The Harmony S/T ventilator is not intended to provide the total ventilatory requirements of the patient. The prescribed patient settings must be adjusted by trained and authorized personnel only. Do not attempt to open the top lid of the unit. Use only the patient circuit provided by your home care provider. When using a patient circuit that contains a Whisper Swivel II or other exhalation device, do not tape, seal, or otherwise block the vent openings. Doing so may result in asphyxia. Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. Exercise caution when using the Harmony S/T ventilator if the room temperature is greater than 95 F (35 C). At high room temperatures, the air from the unit can cause discomfort or irritation to your nasal passages and your airway. Do not use the Harmony S/T if the breathing circuit connection is blocked. When the Harmony S/T ventilator is used with a humidifier, be sure that the humidifier is lower than both the unit and you. Repairs and adjustments must be performed by Respironics-authorized service personnel ONLY. Service done by inexperienced, unqualified personnel or installation of unauthorized parts could cause injury, invalidate the warranty, or result in costly damage. Periodically inspect electrical cords for damage or signs of wear. To avoid electrical shock, unplug the Harmony S/T unit before cleaning it. Immediately report any unusual chest discomfort, shortness of breath, or severe headache to your physician. If the unit is dropped or if you notice any changes in the operation, contact your home care provider. 3 WARNINGS
4 Cautions, Notes Cautions A Caution indicates the possibility of damage to the device. Federal law restricts this device to sale by or on the order of a physician. Do not expose the Harmony S/T ventilator to temperatures at or near the extremes of those shown below. If exposure to such temperatures has occurred, allow the unit to come to room temperature before turning it on. Temperatures Operating: 5 C to 40 C Transport/Storage: -20 C to 60 C The unit must be positioned on its base for proper operation. Do not place the unit such that any side or the bottom of the unit may not have adequate air circulation. A properly installed, undamaged inlet filter is required for proper operation. Never place liquids on or near the Harmony S/T unit. If the External Battery Discharged Alarm is activated, disconnect the external battery immediately. A discharged battery may be damaged if it continues to be connected to the ventilator. Additional Warnings, Cautions, and Notes are located throughout this manual.
Intended Use/Indications for Use The BiPAP Harmony S/T is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. The Harmony S/T is intended for use in the home, hospital, or other institutional settings. Contraindications The Harmony S/T ventilator should not be used if you have severe respiratory failure without a spontaneous respiratory drive. If any of the following conditions apply to you, consult your physician before using the Harmony S/T ventilator. Consult your physician if you have: the inability to maintain a patent airway or adequately clear secretions. a risk of aspiration of gastric contents. acute sinusitis or otitis media. an allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance. epistaxis. hypotension. The following are potential side effects of noninvasive positive pressure therapy: Ear discomfort Conjunctivitis Skin abrasions due to noninvasive interfaces Aerophagia (gastric distention) 5 Intended Use, Contraindications
6 1 Contents of the Package The BiPAP Harmony S/T package contains: Package Contents BiPAP Harmony S/T unit Six feet of tubing Whisper Swivel II exhalation port Gray Foam filter Ultra-fine filter Your home care provider should have pre-assembled the tubing, exhalation port, and mask into a breathing circuit. If any of the items are missing, please contact your home care provider. Harmony S/T Unit Exhalation Port Six Feet of Tubing OPTIONS DC power cord Oxygen valve (required for oxygen use) Bacteria filter Humidifier Disposable Ultra-fine Filter Reusable Gray Foam Filter
2 Introduction to the Harmony S/T 7 What is Bi-Level Ventilation? Bi-level ventilation with the Harmony S/T Ventilatory Support System helps you to breathe by supplying two levels of air pressure. The Harmony S/T provides a higher pressure known as IPAP (Inspiratory Positive Airway Pressure) when you inhale, and a lower pressure known as EPAP (Expiratory Positive Airway Pressure) when you exhale. The higher pressure opens your airway to increase the amount of air going into your lungs, and the lower pressure makes it easier for you to exhale while still keeping your airway open. IPAP Pressure EPAP Pressure The Harmony Ventilator Provides Two Levels of Ventilation. Figure 2-1. BiPAP Breathing Levels. Introduction NOTE: Occasionally, cosmetic changes may be made to the product that do not affect the performance or specifications of the product. These kinds of changes do not warrant a reprinting of this manual. Illustrations are for reference only.
8 Introduction What is the Harmony S/T? The Harmony ventilator, shown in Figure 2-2, supplies two levels of air pressure through a breathing circuit. The circuit consists of: circuit tubing to deliver the air from the ventilator to your interface (e.g., mask) an exhalation port to vent exhaled air from the circuit a mask or other interface to deliver the ventilation to your nose or nose and mouth, depending on which interface has been prescribed for you The system senses your breathing effort and changes pressure levels when you inhale and exhale. Figure 2-2. The Harmony S/T Unit.
Symbols The symbols shown at right are used on the Harmony S/T and throughout this manual. Symbol Meaning Attention, consult accompanying documents 9 How to Contact Respironics AC Power Indicator DC Power Indicator Symbols To have your unit serviced, contact your home care provider. If you need to contact Respironics directly, use the following addresses: Alarms System Alarm Indicator Patient Alarm Indicator START STOP Time at Pressure Rise Time control (patient comfort) Type BF
10 3 A Tour of the Harmony S/T Overview Carrying Handle Tour of the Harmony S/T Figure 3-1 shows the location of the: controls and indicators breathing circuit connection carry handle Controls/ Indicators Breathing Circuit Connection Optional Oxygen Valve Figure 3-1. The Harmony S/T Front and Top.
Rise Top Panel The top panel contains the controls and indicators you will need when you are using the BiPAP Harmony S/T. Start/Stop Switch 11 Start/Stop switch AC Power Indicator DC Power Indicator Patient Alarm System Alarm Rise Time control Pressure Indicator Power Indicators Alarm Indicators Time Control Top Panel The Start/Stop switch starts and stops the unit. The AC and DC power indicators show you whether the Harmony S/T is connected to AC or DC power. The Patient and System alarms alert you when a problem occurs. See Chapter 5 for an explanation of what to do when an alarm is activated. The Rise Time control adjusts the time the pressure takes to go from the lower-level pressure (EPAP) to the higher-level pressure (IPAP). You adjust this control for your comfort. Figure 3-2. The Harmony S/T Top Panel. The controls and indicators contained within the dotted line in Figure 3-2 are covered by a door that prevents the settings from being accidentally changed. Your home care provider has set the controls according to your prescription. The Pressure Indicator and the IPAP and EPAP slides are visible through the window of the door. The Pressure Indicator shows the approximate pressure level produced. The IPAP and EPAP slides light when the unit is in the respective phase of therapy.
12 Circuit Connections, Rear Panel Connecting the Breathing Circuit Figure 3-3 shows where the circuit tubing connects to the Harmony S/T unit. Rear Panel Figure 3-4 shows the location of the: air inlet filters AC inlet DC inlet The Harmony S/T uses a gray pollen filter that is washable and reusable, and a white ultra-fine filter that is disposable. The AC Inlet is where the AC receptacle is connected if you are running the unit from house voltage. The DC Inlet is where the DC plug is connected if you are running the unit from a 12 Vdc source. DC Inlet Patient Interface Port Figure 3-3. Breathing Circuit Connection. DC Cord Retainer AC Inlet Filter Access Panel Figure 3-4. Rear Panel.
4 Using the Harmony S/T 13 Installing the Inlet Filters The Harmony uses a gray foam filter that is reuseable, and an optional white ultra-fine filter that is disposable. One filter of each kind is supplied with Harmony. If your home care provider did not install the inlet filters, you must install at least the gray foam filter before using the Harmony. STEP 1 STEP 2 Place the pollen filter on top of the ultra-fine filter. Slide the filters into the air inlet at the rear of the unit. Reusable Pollen Filter Disposable Ultra-fine Filter Inlet Filter Cover Installing the Air Filters STEP 3 STEP 4 Place the bottom of the inlet filter cover into the bottom of the air inlet opening, making sure that the catches engage the lip of the opening. Swing the top of the cover into place and press down on it to engage the cover catches in the air inlet opening. See Chapter 7 for instructions to clean or replace the filters.
14 Where to Place the Harmony S/T Unit Place the Harmony S/T unit on its base somewhere within easy reach of where you will be using it. Make sure that the air inlet on the rear of the unit is not blocked. If you block the air flow around the unit, the unit may not work properly. Placing the Harmony S/T for Use If you are using a humidifier, be sure to place the humidifier and unit on a placemat or other waterproof material to protect your furniture from moisture. Both you and the Harmony S/T ventilator MUST be positioned higher than the humidifier to prevent the backflow of water into the unit or into your mask. Connecting the Breathing Circuit STEP 1 STEP 2 Connect one end of the six-foot tubing to the large connector on the Harmony unit. Connect the open end of the circuit tubing to the exhalation device. Circuit Tubing Exhalation Device Step 1 Circuit Tubing Step 2
STEP 3 STEP 4 Connect the exhalation device to the mask connector. Attach the Softcap or headgear to the mask see the instructions that came with your Softcap or headgear. Mask Connector Exhalation Device Step 3 Mask or Other Interface 15 Connecting the Breathing Circuit
16 Complete Setup Complete Harmony S/T Setup Figure 4-1 shows the completed breathing circuit setup for the Harmony S/T unit. Exhalation Port Patient Interface (typical) Circuit Tubing Figure 4-1. Harmony S/T Complete Breathing Circuit.
Plugging the Unit In (Using AC Power) STEP 1 Plug the receptacle end of the AC cord into the AC inlet. STEP 2 WARNING: Insert the plug end of the AC cord into the wall outlet. Never plug the Harmony S/T AC cord into an outlet that is controlled by a wall switch. If the External Battery Discharged Alarm is activated, disconnect the external battery immediately. A discharged battery may be damaged if it continues to be connected to the ventilator. 17 Plugging the Unit In Using DC Power STEP 1 Plug the receptacle end of the DC cord into the DC inlet. STEP 2 STEP 3 Leaving some slack in the DC cord, push the DC cord into the DC cord retainer. Insert the adaptor end of the DC cord into the appropriate DC outlet. See the instructions that came with the DC cord for proper DC connections. DC Cord Retainer
18 Starting the Unit Starting the Harmony S/T Unit STEP 1 STEP 2 Press the Start/Stop switch to the START position. The unit will sound two beeps and briefly illuminate all the indicators. This is the internal test performed by the unit. Allow the unit to establish flow and then put on your mask assembly. NOTE: If the unit does not sound the two beeps or illuminate the indicators, do not try to use the unit. Contact your home care provider. STEP 3 Make sure that no air is leaking from your mask into your eyes. If it is, adjust the mask and Softcap or headgear until air stops leaking into your eyes. See the instructions that came with your mask. STEP 5 Relax. Take slow, relaxed breaths through your nose. NOTE: If you are having trouble with your mask, see Chapter 6 for some suggestions. Adjusting the Rise Time The Rise Time is the time it takes for the Harmony to change from EPAP to IPAP (See Chapter 2). You can adjust this time to meet your comfort needs by moving the Rise Time control (See Figure 3-2). The control changes from a faster rise time on the left to a slower rise time on the right. STEP 4 If you are using the Harmony while sleeping, place the tubing from the Harmony unit over your headboard to reduce tension on the mask. NOTE: A small amount of mask leak is normal and acceptable. Large mask leaks or eye irritation from an air leak should be corrected as soon as possible.
5 Alarms and What to Do This chapter describes the Harmony S/T alarms and what you should do if an alarm is activated. The Harmony S/T unit provides two types of alarms, System and Patient. Both types are indicated by visual and audible alarms. The visual alarms are LEDs located on the right side of the front panel, as shown in Figure 5-1. Symbol Meaning Off On Flashing System Alarm LED 19 Alarms If an alarm sounds, check which LED is on and refer to the table on the next page for an explanation and possible corrective actions. If the suggested actions do not stop the alarm, contact your home care provider. Patient Alarm LED Figure 5-1. Alarm Indicator Locations.
20 WHAT YOU SEE WHAT YOU HEAR WHAT THE UNIT DOES WHY THE ALARM SOUNDED WHAT TO DO Alarms AC LED Off DC LED Off System LED On Continuously Patient LED Off Continuous Tone Unit not working Loss of input power Be sure that the AC power cord is plugged into a working outlet or the DC power cord is connected to a charged battery. AC LED On OR DC LED On System LED On Continuously Continuous Tone Unit not working Internal failure Contact your home care provider for service. Patient LED Off AC LED On OR DC LED On System LED On Continuously Patient LED Off Intermittent Beeps Unit is operating Unable to reach prescription Check the inlet filters as described in Chapter 7. If the filters are OK, contact your home care provider for service.
WHAT YOU SEE WHAT YOU HEAR WHAT THE UNIT DOES WHY THE ALARM SOUNDED WHAT TO DO 21 AC LED On OR DC LED On System LED On Continuously Patient LED Off Intermittent Beeps Unit not working Internal Failure Contact your home care provider for service. Alarms AC LED Off DC LED Off System LED On Continuously Patient LED Off Intermittent Beeps Unit not working External battery discharged Check the external battery or seek an alternate power source. System LED Off Patient LED On Intermittent Beeps Unit is operating Patient Disconnect Be sure that the breathing circuit and mask are connected properly. AC LED Off DC LED Off Three beeps every 30 seconds Unit is operating AC and DC power sources were both connected and AC power was lost while the ventilator was running Reconnect the AC power and restart the unit, or disconnect the AC power cord and restart the unit so that it runs from DC.
22 WHAT YOU SEE WHAT YOU HEAR WHAT THE UNIT DOES WHY THE ALARM SOUNDED WHAT TO DO Alarms AC LED Off DC LED Flashing Three beeps every 15 seconds Unit is operating Low external battery The external battery is about to fail. Seek an alternate power source.
6 Troubleshooting 23 This chapter lists problems you could experience with your Harmony unit or mask, and presents possible solutions. PROBLEM The air out of the mask is much warmer than usual. WHY IT HAPPENED Inlet filters may be dirty. WHAT TO TRY Clean or replace the inlet air filters as described in Chapter 7. If the problem persists, contact your home care provider. Troubleshooting Pressure delivery shown by the pressure bar graph is much less than the setting on the IPAP or EPAP controls.* No air flow from the unit when the power switch is placed in the START position. Inlet filters may be dirty. Problems in the Harmony S/T unit. Clean or replace the inlet air filters as described in Chapter 7. If the problem persists, contact your home care provider. Contact your home care provider for service. *The pressure bar graph is not intended to be an accurate indicator of the pressure level. However, it should not be off by a large amount.
24 Mask Discomfort and Corrective Actions Problem Why it Happened What to Try Mask Problems Mask feels uncomfortable to wear. 1. Improper Softcap or headgear adjustment. 2. Improper mask fitting. Check the Softcap or headgear adjustment as described in the Softcap or headgear instructions. Contact your home care provider for a refitting or a different size of mask. Significant air leakage around the mask 1. Improper Softcap or headgear adjustment. Check the Softcap or headgear adjustment as described in the Softcap or headgear instructions. 2. Improper mask fitting. Contact your home care provider for a refitting or a different size of mask. Redness occurs when the mask cushion or Comfort Flap mask accessory comes in contact with the skin. 1. Improper mask fitting. 2. Improper mask cleaning. Contact your home care provider for a refitting or a different size of mask. Be sure to thoroughly rinse after cleaning to remove residue. See the mask cleaning instructions.
25 Problem Why it Happened What to Try Redness occurs when the mask cushion or Comfort Flap mask accessory comes in contact with the skin. Sore or dry eyes 3. Irritation or allergic reaction to mask material. 1. Mask not positioned properly. Use a barrier between your skin and the mask, such as 3M s Microfoam or Squibb s Duoderm. Check the Softcap or headgear adjustment as described in the Softcap or headgear instructions. Mask Problems 2. Improper mask fitting. Contact your home care provider for a refitting or a different size of mask. Runny nose Nasal reaction to air flow. Call your doctor.
26 Problem Why it Happened What to Try Mask Problems Throat or nose dryness Nasal, sinus or ear pain 1. Air is too dry. 2. Improper mask fitting. Sinus or middle ear infection 1. Increase the room humidity. 2. Consult with your doctor or home care provider about using a Respironics humidifier with the ventilator. Stop using the Harmony S/T ventilator and contact your doctor.
7 Cleaning the Unit and Filters Cleaning Your Harmony Unit Before cleaning or performing any routine maintenance, always switch the start/stop switch to and disconnect the unit from the power source. NOTE: The following cleaning instructions are for the Harmony unit only. To clean the circuit and accessories, refer to each accessory s instruction sheet. WARNING: Do not immerse the Harmony unit or allow any liquid to enter the cabinet or inlet filter. 27 Cleaning and Maintenance Clean the unit with a cloth dampened with water and a mild detergent, or with 70% Isopropyl Alcohol only.
28 Inlet Filters Cleaning/Replacing the Inlet Filters The Harmony unit has two removable filters at the air inlet. The gray foam filter is washable and reusable. The optional white ultra-fine filter is disposable. CAUTION: Dirty inlet filters may cause high operating temperatures and may affect ventilator performance. Periodically examine the inlet filters for integrity and cleanliness. Step 1 Turn the Harmony unit start/stop switch to the STOP position and disconnect the power cord from the wall outlet. Step 2 Remove the filter panel by pressing down on the top of the panel to release the tabs, then swinging the panel out from the unit s body. Step 2 Step 3 Remove the filters from the enclosure. The top filter is the reusable gray foam filter. The bottom filter is the optional disposable white ultra-fine filter. Step 4 Check the filters to see if they are dirty or torn. Reusable Gray Foam Filter Disposable Ultra-fine Filter Step 3
Step 5 If needed, wash the gray foam filter in warm, soapy water. Rinse the filter thoroughly to remove all soap residue. Allow the filter to completely dry before reinstalling it. Use the extra gray foam filter that was supplied with your Harmony unit while the wet filter dries. If the gray foam filter is torn, replace it. Step 6 If the ultra-fine filter is dirty or torn, replace it. 29 Inlet Filters Step 7 Replace the filters with the ultra-fine filter on the bottom. Step 8 Replace the filter panel. Contact your home care provider to order filters. NOTE: To clean the patient circuit accessories, refer to each accessory s instruction sheet.
30 Using Oxygen 8 Using Oxygen with your Harmony Ventilator If your doctor has prescribed oxygen to be used with your Harmony S/T, follow these instructions to connect oxygen to the breathing circuit. WARNING: WARNING: If you are using oxygen, your Harmony S/T must be equipped with the optional oxygen valve, shown in Figure 8-1. Failure to use the oxygen valve could result in a fire hazard. Contact your home care provider if you require oxygen, but an oxygen valve has not been supplied on the ventilator. Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. Oxygen tubing from the oxygen valve can be connected either to the mask or to an oxygen enrichment adaptor. If using the adaptor, you must place it in the breathing circuit between the air outlet of the Harmony S/T unit and the breathing circuit tubing. Optional Oxygen Valve Figure 8-1. Optional Oxygen Valve.
Step 1 As shown in Figure 8-2, attach oxygen tubing to the rear oxygen valve port. The oxygen valve prevents oxygen from entering the Harmony S/T enclosure when the unit is stopped. Step 2 Connect another section of oxygen tubing to the front valve port, then to the oxygen enrichment adaptor in the breathing circuit or to one of the sample ports on the mask. Step 3 Turn the Harmony S/T ventilator on before turning on the oxygen supply. Step 4 Turn the oxygen flow on. Circuit Tubing Oxygen Enrichment Attachment Oxygen Valve From Oxygen Source Figure 8-2. Attaching oxygen tubing to the Harmony S/T. 31 Using Oxygen Exhalation Port Oxygen Tubing from Oxygen Shut-Off Valve Figure 8-3. Attaching oxygen tubing to mask port.
32 A AC Indicator 11 AC Inlet 12 Air Inlet Filters 12 Alarms 19 Patient 11 System 11 What to Do 19 B Bi-Level Ventilation 7 Breathing Circuit 8 Complete 16 Connection 10, 14 C Cautions 4 Cleaning and Maintenance 27 Cleaning Your Harmony Unit 27 Cleaning/Replacing the Inlet Filters 28 29 Comfort control 11 Contents of Package 6 Contraindications 5 Index D DC Indicator 11 DC Inlet 12 E EPAP 7 EPAP control 11 Exhalation Port 15 Expiratory Positive Airway Pressure 7 F Filters Cleaning/Replacing 28 29 H Harmony S/T Ventilator Breathing Circuit 8 Cleaning 27 Connections 10 Starting 18 Top Panel 10 Touring 10
What it is 8 Where to Locate 14 I Indicators AC 11 DC 11 Inlet Filters Cleaning/Replacing 28 29 Inspiratory Positive Airway Pressure 7 Installing the Inlet Filters 13 Interface 8 Introduction 7 IPAP 7 IPAP Control 11 L Limited Warranty 35 Location 14 M Mask 8 Mask Discomfort Corrective Action 24 O Oxygen Connecting 30 Valve 31 P Package Contents 6 Patient Alarm 11 Plugging the Unit In 17 Pressure Indicator 11 R Rear Panel 12 Respironics How to Contact Us 9 S Start/Stop switch 11 Starting the Harmony Unit 18 Symbols 9 System Alarm 11 33
34 T Temperatures operating, storage 4 Top Panel Components of 11 Troubleshooting 23 Tubing Breathing Circuit 6, 12, 14 V Ventilation, bi-level 7 W Warnings 3 Warnings, Cautions, and Notes 3 Warranty 35
Limited Warranty 35 Respironics, Inc. warrants that the BiPAP Harmony S/T System shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of one (1) year from the date of sale by Respironics, Inc. to the dealer. If the product fails to perform in accordance with the product specifications, Respironics, Inc. will repair or replace at its option the defective material or part. Respironics, Inc. will pay customary freight charges from Respironics, Inc. to the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse, alteration, and other defects not related to material or workmanship. Respironics, Inc. disclaims all liability for economic loss, loss of profits, overhead or consequential damages which may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This warranty is given in lieu of all other express warranties. In addition, any implied warranties including any warranty of merchantability or fitness for the particular purpose are limited to one year. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state. To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contact Respironics, Inc. at: 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550 1-412-731-2100
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